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Melatonin in Relapsing-Remitting Multiple Sclerosis Patients

This study is currently recruiting participants.
Verified July 2011 by Tehran University of Medical Sciences
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01279876
First received: January 18, 2011
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to determine whether melatonin is effective in the treatment of relapsing-remitting multiple sclerosis patients as a supplement to the main disease-modifying drugs.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
 Drug: Melatonin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Melatonin on Clinical and Neuroimaging Indices of Relapsing-Remitting Multiple Sclerosis Patients

Resource links provided by NLM:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Number of relapses [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • EDSS [ Time Frame: one year (every 3 months) ] [ Designated as safety issue: Yes ]
    Expanded Disability Status Scale reported by a neurologist

  • PASAT-3 score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]
    Paced Auditory Serial Addition Test 3seconds score

  • proportion of brain gray matter volume to intracranial volume [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MSFC score [ Time Frame: one year (at the beginning and end of the year) ] [ Designated as safety issue: No ]
    Multiple Sclerosis Functional Composite score (Timed 25-foot score + 9-hole peg test score + PASAT-3 score)


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin Drug: Melatonin
3mg oral, daily, one hour before sleep
Placebo Comparator: Placebo Drug: Melatonin
3mg oral, daily, one hour before sleep

Detailed Description:

Multiple sclerosis is an autoimmune chronic demyelinating disorder of the central nervous system, and the major cause of disability in the youngsters all over the world, still with no definitely known etiology and treatment. Melatonin is a hormone secreted by pineal gland famous for its role in circadian rhythm regulation, and with known antioxidant effects. It was shown that melatonin is lower in multiple sclerosis patients in the relapse phase in comparison to other diseases and is correlated with the Multiple Sclerosis Functional Composite score of the patients. Melatonin is also suggested to have an immunomodulatory role. Therefore, we hypothesize that melatonin can be effective in the treatment of relapsing-remitting multiple sclerosis patients.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • definite diagnosis of relapsing-remitting multiple sclerosis
  • EDSS <=5
  • at least 6months consumption of interferon beta 1a

Exclusion Criteria:

  • illiteracy
  • evidence of Nystagmus or visual acuity lower than 5/10 in each of the eyes
  • relapse in the last 3 months
  • pregnancy or deciding to become pregnant during the following year
  • regulatory consumption of warfarin, nifedipine, nonsteroidal anti-inflammatory drugs (NSAIDs), beta-blockers, fluvoxamine, isoniazide, progestin
  • history of epilepsy, stroke, major depression, endocrine, hepatic, hematologic, and nephrologic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279876

Contacts
Contact: Mohammad Hossein Harirchian, M.D. 88733731 ext +9821 harirchn@hotmail.com

Locations
Iran, Islamic Republic of
Iranian Center for Neurological Researches, Imam Khomeini Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohammad Hossein Harirchian, M.D.     88733731 ext +9821     harirchn@hotmail.com    
Principal Investigator: Mohamad Hossein Harirchian, M.D.            
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Mohammad Hossein Harirchian, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Mohammad Hossein Harirchian, Tehran University of Medical Science
ClinicalTrials.gov Identifier: NCT01279876     History of Changes
Other Study ID Numbers: 8153-54-04-87
Study First Received: January 18, 2011
Last Updated: July 25, 2011
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
 Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013